BOSTON, Oct. 19 /PRNewswire-FirstCall/ -- NMT Medical, Inc. announced today that it has received approval to begin enrollment in MIST III (Migraine Intervention with STARFlex(R) Technology). Approval was granted by the regulatory authorities in the United Kingdom where the trial will be conducted.
In MIST III, control patients from the original MIST study, those who did not receive the STARFlex(R) implant, have the option to receive an implant after they have been unblinded as part of the MIST study. These patients will be followed for 18 months and will become their own control. In addition, migraine patients with a PFO (patent foramen ovale) who did receive a STARFlex(R) implant in MIST will be followed for an additional 18 months.
John E. Ahern, NMT's President and Chief Executive Officer, said, "With MIST III approval, NMT now has five PFO-related clinical trials underway. We are not aware of any other companies having approval for more than one such study. The approval of MIST III further demonstrates NMT's leadership in the PFO-closure field."
About NMT Medical, Inc.
NMT Medical is an advanced medical technology company that designs, develops and markets proprietary implant technologies that allow interventional cardiologists to treat cardiac sources of migraine headaches, stroke and other potential brain attacks through minimally invasive, catheter- based procedures. NMT Medical is investigating the potential connection between a common cardiac defect called a PFO and brain attacks such as migraine headaches, stroke and transient ischemic attacks (TIAs). A PFO can allow venous blood, unfiltered and unmanaged by the lungs, to enter the arterial circulation of the brain, possibly triggering a cerebral event or brain attack. More than 18,000 PFOs have been closed globally with NMT's implant technology.
The prevalence of migraines in the United States is about 10%. Of the 28 million migraine sufferers in America, those who experience aura and have a PFO may represent a three million patient subset. Stroke is the third leading cause of death in the United States and the leading cause of disability in adults. Each year, 750,000 Americans suffer a new or recurrent stroke and 500,000 Americans experience a TIA.
The Company also serves the pediatric interventional cardiologist with a broad range of cardiac septal repair implants delivered with nonsurgical catheter techniques. For more information about NMT Medical, please visit http://www.nmtmedical.com.
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements -- including statements regarding the outcomes of the Company's MIST III clinical trial, the Company's market opportunities, including migraines, and regulatory approvals for the Company's products -- involve known and unknown risks, uncertainties or other factors which may cause actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Factors that may cause such a difference include, but are not limited to, the timing and outcome of the Company's BEST, MIST, MIST II, MIST III and CLOSURE I clinical trials, the Company's ability to develop and commercialize new products, a potential delay in the regulatory process with the U.S. Food and Drug Administration and foreign regulatory agencies, as well as risk factors discussed under the heading "Certain Factors That May Affect Future Results" included in Management's Discussion and Analysis of Financial Condition and Results of Operations in the Company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2005 and subsequent filings with the U.S. Securities and Exchange Commission.
Contact: John E. Ahern President and Chief Executive Officer NMT Medical, Inc. (617) 737-0930 jea@nmtmedical.com
NMT Medical, Inc.CONTACT: John E. Ahern, President and Chief Executive Officer of NMTMedical, Inc., +1-617-737-0930, jea@nmtmedical.com
Web site: http://www.nmtmedical.com//
